Preterm Birth
Conditions
Keywords
Short cervix, Preterm birth, Cervical pessary, Twins
Brief summary
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with twins and a short cervical length at 18-22 weeks scan.
Detailed description
This trial includes pregnant women with twins undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.
Interventions
DEVICESilicon ring (Arabin Cervical Pessary)
Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003
Sponsors
Maternal-Infantil Vall d´Hebron Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Twins * Minimal age of 18 years
Exclusion criteria
* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap) * Spontaneous rupture of membranes at the time of randomization * Cervical cerclage in situ * Active vaginal bleeding * Placenta previa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous delivery before 34 completed weeks | Each 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Fetal-Neonatal Death | Each 6 months |
| Neonatal morbidity | Each 6 months |
| Maternal adverse effects | Each 6 months |
| Birth weight | Each 6 months |
| Rupture of membranes before 34 weeks | Each 6 months |
| Hospitalisation for threatened preterm labour | Each 6 months |
| Preterm birth before 37 weeks or 28 weeks | Each 6 months |
Countries
Spain
Outcome results
None listed